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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-930PA

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NIHON KOHDEN CORPORATION ZM-930PA Back to Search Results
Model Number ZM-930PA
Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)
Patient Problems Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
The customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage. In the process the nurse that was handling the device got burned. The incident took place on (b)(6) 2016 at 11:00am. As a result of the burn, the nurses hand turned red. She flushed it with cool water and the redness went away shortly. The nurse stated that the injury was not life-threatening and did not result in permanent impairment of the body. The injury did not necessitate medical or surgical intervention. The customer stated that they were not suing the recommended batteries, they were using the cheap batteries. The device was returned to nihon kohden for evaluation. The device was evaluated for possible short circuits and none were found. Battery used by customer is not equivalent to recommended battery.
 
Manufacturer Narrative
Customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage. In the process the nurse that was handling the device got burned. The incident took place on (b)(6) 2016 at 11:00am. As a result of the burn, the nurses hand turned red. She flushed it with cool water and the redness went away shortly. The nurse stated that the injury was not life-threatening and did not result in permanent inpairment of the body. The injury did not necessitate medical or surgical intervention. The customer stated that they were not using the recommended batteries, they were using the cheap batteries. The device has been returned to nihon kohden and is undergoing evaluation. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
 
Event Description
Customer reported that the transmitter got hot, staff smelled smoke, the batteries got hot and expanded, and caused case damage. In the process the nurse that was handling the device got burned.
 
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Brand NameZM-930PA
Type of DeviceZM-930PA
Manufacturer (Section D)
NIHON KOHDEN CORPORATION
1-31-4 nishiochia, shinjuku-ku
tokyo, japan 161-8 560
JA 161-8560
Manufacturer (Section G)
NIHON KOHDEN TOMIOKA CORPORATION
486 nanokaichi
tomioka city, japan 370-2 343
JA 370-2343
Manufacturer Contact
thomas bento
1-31-4 nishiochia, shinjuku-ku
tokyo, japan 161-8-560
JA   161-8560
2687708
MDR Report Key5682226
MDR Text Key257731143
Report Number8030229-2016-00216
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K946175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/26/2016,04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberZM-930PA
Device Catalogue NumberZM-930PA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Report Sent to FDA05/26/2016
Distributor Facility Aware Date04/27/2016
Device Age62 MO
Event Location Hospital
Date Report to Manufacturer05/26/2016
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/26/2016 Patient Sequence Number: 1
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